HYDROCORTISONE CREAM

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HYDROCORTISONE CREAM (HYDROCORTISONE CREAM)

Composition:

Active substance: hydrocortisone;

1 g of the preparation contains 1 mg of hydrocortisone butyrate;

Excipients: cetostearyl alcohol, polyethylene glycol cetostearyl ether, mineral oil, white soft paraffin, methylparaben (E 218), propylparaben (E 216), citric acid, sodium citrate, purified water.

Pharmaceutical form. Cream.

Main physico-chemical characteristics: white-colored cream.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code: D07AB02.

Pharmacological Properties

Pharmacodynamics

Hydrocortisone butyrate is an active synthetic non-halogenated corticosteroid for topical use. It exerts anti-inflammatory, anti-edematous, and antipruritic effects. Its efficacy is comparable to that of halogenated steroids. Use at recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system. Although prolonged use of large doses of the drug, especially when occlusive dressings are used, may lead to increased plasma cortisol levels, the responsiveness of the pituitary-adrenal system remains unaffected, and cortisol production normalizes after discontinuation of the drug.

Pharmacokinetics

Absorption. After application, accumulation of the active substance occurs in the epidermis, primarily in the stratum granulosum.

Metabolism. Hydrocortisone butyrate, absorbed through the skin, is metabolized to hydrocortisone and other metabolites directly in the epidermis, and subsequently in the liver.

Elimination. Metabolites and a minor portion of unchanged hydrocortisone butyrate are excreted in urine and feces.

Clinical characteristics.

Indications.

Conditions that respond to treatment with topical corticosteroids (eczema, dermatitis, psoriasis). Topical corticosteroids are generally not indicated for the treatment of psoriasis, but may be acceptable except for widespread plaque psoriasis, provided that precautions are observed (see section "Special precautions for use").

Contraindications.

Except in cases of treatment combined with appropriate chemotherapeutic agents:

• skin lesions (wounds) caused by bacterial infections (e.g., pyoderma, syphilitic or tuberculous lesions), viral infections (e.g., varicella, herpes simplex, herpes zoster, common warts, flat warts, genital warts, molluscum contagiosum); infections caused by fungi and yeasts; parasitic infections (e.g., scabies);
• ulcerative skin lesions;
• adverse reactions induced by corticosteroids (e.g., perioral dermatitis, striae);
• ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, skin telangiectasia, skin atrophy;
• hypersensitivity reactions to components of the medicinal product or to corticosteroids (the latter are rare);
• skin neoplasms.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use

Systemic adverse reactions with topical corticosteroids in adults are extremely rare but can be serious, particularly adrenal cortical suppression with prolonged use of the drug.

Risk of systemic effects is increased in the following cases:

• application over large areas of skin, especially when using occlusive dressings or application to skin folds;
• long-term treatment;
• use in children (due to thinner skin and relatively larger body surface area);
• presence of components or excipients that enhance penetration through the stratum corneum and/or potentiate the effect of the active substance (e.g. propylene glycol).

Risk of local adverse reactions increases with increasing potency of the drug and duration of treatment. Use with occlusive dressings or application to skin folds increases this risk. Facial skin, scalp, and genital areas are particularly susceptible to adverse reactions. With inappropriate use, as well as in the presence of bacterial, parasitic, fungal, or viral infections, manifestations of these diseases may be masked and/or exacerbated.

The cream should not be applied to the eyelids due to the possibility of contact with the conjunctiva and increased risk of developing open-angle glaucoma or subcapsular cataract.

Topically applied corticosteroids may be hazardous in patients with psoriasis for several reasons, including rebound syndrome due to development of tolerance, risk of generalized pustular psoriasis, or local and systemic toxic effects resulting from impaired skin barrier function. Steroids may be used in cases of scalp psoriasis or chronic plaque psoriasis of hands and feet. Close monitoring of patients is essential.

Children, including infants.

There is a potential for adverse effects in infants with excessive use. Particular caution should be exercised in skin disorders in infants, such as diaper dermatitis. In such patients, treatment duration should not exceed 7 days.

Adrenal suppression (Cushing's syndrome) may develop rapidly in children. Suppression of growth hormone production and intracranial hypertension may also occur. Signs of intracranial hypertension include bulging fontanelle, headache, and bilateral optic disc swelling. If long-term treatment is required, regular monitoring of the child's height and body weight, as well as plasma cortisol levels, is advisable.

No significant differences in adrenal cortical function were observed in children treated with hydrocortisone butyrate cream or 1% hydrocortisone at doses of 30–60 grams per week over 4 weeks.

Excipients in the medicinal product.

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Propylparaben and methylparaben may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

Pregnancy. Data on the use of hydrocortisone butyrate in pregnant women are lacking or limited. Animal studies indicate reproductive toxicity of the drug. Corticosteroids cross the placenta. Systemic use of high doses of corticosteroids has been associated with effects on the fetus or newborn (fetal growth retardation, adrenal cortical suppression).

Despite limited information on the use of corticosteroids on the skin during pregnancy, due to limited systemic absorption of drugs in this class, short-term use of weak and moderately potent corticosteroids (class 1 and class 2), such as hydrocortisone, on limited skin areas may be considered. However, the aforementioned effects cannot be excluded with prolonged use or application over large skin areas. Such use should only be considered when specifically indicated.

Breastfeeding period. Hydrocortisone butyrate/metabolites pass into breast milk; however, when the drug is used at therapeutic doses, no effect on newborns/infants who are breastfed is expected. The medicinal product may be used in women during breastfeeding only for short-term treatment and on small skin areas. With long-term treatment or application over large areas of affected skin, breastfeeding should be discontinued.

Ability to affect reaction rate while driving or operating machinery.

There are no data on the effect of HYDROCORTISONE CREAM on the ability to drive or operate machinery. Such an effect is not expected.

Method of Administration and Dosage

For topical use.

Apply a small amount of the medicinal product in a thin, even layer to the affected areas no more than twice daily.

Application under occlusive dressing may be used in the presence of more resistant lesions, such as thickened psoriatic plaques on elbows and knees (except for weeping lesions).

Dosage

The total cumulative dose should not exceed 30–60 g of cream per week.

Adults and elderly patients

Adults and elderly patients should receive the same dosage, as there are no clinical data indicating that elderly patients require a special dosing regimen.

Children

Prolonged treatment should be avoided, if possible.

From 6 months to 1 year of age

If possible, the treatment period should not exceed 7 days.

Overdose.

Excessive use under occlusive dressing may lead to adrenal suppression. There are no specific antidotes or treatment procedures. If any adverse effects occur, treatment should be discontinued and symptomatic therapy initiated.

Side effects.

Uncommon (> 1/10,000, < 1/1,000)

Skin and subcutaneous tissue disorders:

• dermatitis, eczema, striae, contact dermatitis;
• allergic contact dermatitis, pustular acne;
• skin atrophy, often irreversible, accompanied by epidermal thinning, telangiectasia, purpura, and striae;
• depigmentation, hypertrichosis;
• rosacea-like and perioral dermatitis, with or without skin atrophy;
• rebound effect, which may lead to steroid dependence;
• delayed wound healing;
• skin infection, redness, irritation, burning, rash, itching, dryness of the skin, folliculitis, miliaria, acne, maceration.

Endocrine disorders: adrenocortical suppression, Cushing's syndrome, hyperglycemia, glucosuria, growth retardation, and intracranial hypertension.

Very rare (< 1/10,000, including isolated reports)

Eye disorders: increased intraocular pressure and risk of cataract development (with repeated exposure of the drug to the conjunctiva).

Immune system disorders: hypersensitivity reactions.

Reporting of side effects

It is important to report suspected side effects after drug registration. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Do not refrigerate. Keep out of reach of children.

Packaging.

15 g or 30 g in a tube, 1 tube in a cardboard box.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of its business activities.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.

(all stages of manufacturing, quality control, batch release)

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100, letter B-II (building 4).

(all stages of manufacturing, batch release)